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Testing Mestinon and Exercise in Fibromyalgia

This study has been completed.
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00535587
First received: September 21, 2007
Last updated: March 23, 2011
Last verified: March 2011
History of Changes
  Purpose

The purpose of this trial was to test the combined and independent effects of 6 months of exercise and Mestinon in people with fibromyalgia. Specifically, we wanted to determine if Mestinon helped people with fibromyalgia have an easier time exercising and if their symptoms improved by the end of the trial.


Condition Intervention Phase
Fibromyalgia
 Behavioral: Exercise
Drug: pyridostigmine
Drug: Placibo
Behavioral: Attention Control
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Maximizing Exercise Effectiveness in Fibromyalgia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Levels of Growth Hormone Post Exercise [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Serum growth hormone at peak V02/treadmill


Secondary Outcome Measures:
  • Improvement of Fibromyalgia Symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 178
Study Start Date: September 2002
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Behavioral: Exercise Drug: pyridostigmine
Other Name: Mestinon
Experimental: 2 Drug: pyridostigmine
Other Name: Mestinon
Drug: Placibo
Experimental: 3 Behavioral: Exercise Behavioral: Attention Control
Experimental: 4 Drug: Placibo Behavioral: Attention Control

Detailed Description:

Earlier, we demonstrated that people with fibromyalgia fail to make adequate growth hormone when they exercise intensively. We also demonstrated that a single dose of Mestinon helped people make normal levels of growth hormone when they exercised in our laboratory. We wanted to know if 6 months of exercise with concurrent Mestinon therapy would make growth hormone (and related markers) normal and improve fibromyalgia symptoms.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have Fibromyalgia

Exclusion Criteria:

  • Subjects will be excluded if they have a history of rheumatic disease or other disorder that may compromise ability to safely complete study protocol, be pregnant, nursing, or currently involved in unresolved litigation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535587

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97219
Sponsors and Collaborators
Oregon Health and Science University
National Institute of Nursing Research (NINR)
Investigators
Study Director: Edit Serfozo, MPH Oregon Health and Science University
Principal Investigator: Kim Dupree Jones, PhD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Kim Dupree Jones PhD, Associate Professor, Oregon Health & Science University, School of Nursing
ClinicalTrials.gov Identifier: NCT00535587     History of Changes
Other Study ID Numbers: 5R01NR8150-04, R01NR008150
Study First Received: September 21, 2007
Results First Received: March 21, 2011
Last Updated: March 23, 2011
Health Authority: United States: Federal Government

Keywords provided by Oregon Health and Science University:
Fibromyalgia
Exercise
Mestinon

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pyridostigmine Bromide
 Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013